Effects of Growth Hormone Releasing Hormone in HIV
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ClinicalTrials.gov Identifier: NCT01263717 |
Recruitment Status :
Completed
First Posted : December 21, 2010
Results First Posted : October 13, 2014
Last Update Posted : October 30, 2017
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Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
HIV HIV Lipodystrophy |
Interventions |
Drug: tesamorelin Drug: placebo |
Enrollment | 54 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Tesamorelin | Placebo (Inactive Injection) |
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Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose | Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase |
Period Title: Overall Study | ||
Started | 28 | 26 |
Baseline Visit | 28 | 22 |
Completed | 23 | 20 |
Not Completed | 5 | 6 |
Baseline Characteristics
Arm/Group Title | Tesamorelin | Placebo (Inactive Injection) | Total | |
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Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose | Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase | Total of all reporting groups | |
Overall Number of Baseline Participants | 28 | 22 | 50 | |
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[Not Specified]
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 28 participants | 22 participants | 50 participants | |
49
(46 to 54)
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53
(49 to 58)
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51.5
(46 to 56.25)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 28 participants | 22 participants | 50 participants | |
Female |
4 14.3%
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4 18.2%
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8 16.0%
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Male |
24 85.7%
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18 81.8%
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42 84.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 28 participants | 22 participants | 50 participants |
White | 20 | 14 | 34 | |
Black | 6 | 3 | 9 | |
Hispanic | 1 | 3 | 4 | |
Other | 1 | 2 | 3 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 28 participants | 22 participants | 50 participants |
28 | 22 | 50 |
Outcome Measures
Adverse Events
Limitations and Caveats
Please note that we intended to collect and analyze data on PAI1 and tPA but we did not have sufficient funds to do this.
More Information
Results Point of Contact
Name/Title: | Steven K. Grinspoon, MD |
Organization: | Massachusetts General Hospital |
Phone: | 617-724-9109 |
EMail: | sgrinspoon@partners.org |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Steven K. Grinspoon, MD, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01263717 |
Other Study ID Numbers: |
2007p-000638 |
First Submitted: | December 16, 2010 |
First Posted: | December 21, 2010 |
Results First Submitted: | September 8, 2014 |
Results First Posted: | October 13, 2014 |
Last Update Posted: | October 30, 2017 |